Kornimate/medical-research-clean huggingface dataset:
development of a constipation risk assessment scale for hospitalized patients.

Conditions: Constipation

Summary: develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

constipation remains a prominent problem in the hospital care setting given the accumulation of contributing factors. indeed, one of the most common causes of constipation is the existence of irregular habits in stool schedules, including the fact of delaying the time to go to the toilet, which causes the subject for a prolonged period of time to inhibit symptoms. defecation reflexes. these disorders are often increased by the lack of exercise and prolonged bed rest, which cause a lack of muscle of the abdominal strap, the abdominals not being able to play their role of compression. some drugs are also a major cause of the difficulty of intestinal elimination, including opiates, anticholinergics, anti-depressants, etc. finally, an unbalanced diet, a water deficiency are aggravating factors, as is anxiety. in the medical and para-medical literature, there is no complete and validated tool for assessing the risk of constipation at the admission of a hospital stay. this project is to develop a constipation risk assessment scale, which can be used autonomously by nurses, based on the risk factors identified in the literature, scales published in english, and 2007 recommendations from the french national society of gastroenterology, recommendations of the high authority of health and a consensus of experts. the use of such a tool would make it possible to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

Eligibility criteria:
inclusion criteria: * male or female 18 years or older * swallowing, drinking and eating * hospitalized in one of the participating services * hospitalized for a period of at least 4 days * able to give informed consent and answer questions about his or her lifestyle exclusion criteria: * patient with major constipation at baseline (no stool for at least 6 days) * history of intestinal surgery during the 10 days preceding the study, * hospitalized in palliative care or bed identified palliative care.

Keywords: hospitalized patients
a comparison of advanced imaging techniques in aortic stenosis

Conditions: Aortic Stenosis

Summary: in patients with aortic stenosis the valve through which blood is pumped out of the main heart chamber is narrowed. this results in heart muscle working harder to open the valve so blood can circulate around the body. the muscle adapts to the increased pressure load to maintain efficiency. this can cause long-term muscle damage. to predict when this deterioration will require a valve replacement is difficult and untimely operation exposes patients to unnecessary risk. we aim to compare all validated techniques looking at different aspects of heart muscle strain in these patients. these will be a blood sample measuring a specific hormone (bnp) and enzyme (troponin), a nuclear scan to assess nerve activation, an mri identifying scarring and an exercise echocardiogram that measures heart muscle response and pressure changes across the valve. tests will be performed at recruitment and either after one year or after valve replacement, which ever comes first. in comparing these different imaging techniques we aim to identify patients who will benefit from an early operation, those whose muscle is likely to recover back to normal and which patients it is safe to wait longer for the surgery, avoiding unnecessary risk. the results of the study will benefit patients as it will help doctors more accurately assess the timing of valve surgery and improve their prediction of long term heart muscle recovery. it may also increase convenience in clinical management by reducing unnecessary tests and hospital trips. this would translate into cost savings for the nhs.


Eligibility criteria:
inclusion criteria: (group a) * asymptomatic patients with moderate to severe aortic stenosis * ejection fraction greater than 50% * not yet being considered for valve surgery (group b) * severe aortic stenosis (as per esc guidelines) * listed for immediate aortic valve replacement exclusion criteria: (group a and b) * inability to provide informed consent * concurrent primary valve lesions greater than mild (as defined by esc criteria) * previous myocardial infarction (regional wall motion abnormality on resting echo) * cardiomyopathy * congenital heart disease * previous cardiac surgery * renal failure (ckd stage 3, egfr \>30ml/min/1.73m2) * pregnancy, risk of pregnancy, breast feeding

Keywords: left ventricular function aortic valve replacement late gadolinium enhancement cardiac i123 mibg longitudinal strain brain natriuretic peptide high sensitivity troponin i
once daily given alfuzosin in the treatment of bph

Conditions: Benign Prostatic Hyperplasia

Summary: collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /alfetim uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice


Eligibility criteria:
inclusion criteria: * sexually active male patient with lower urinary tract symptoms indicative of severe bph, at whom disturbances of urinary retention and urination are present exclusion criteria: * necessity of surgical intervention immediately or within 12 months because of bph * the patient has earlier /within 6 months/ obtained treatment because of bph * the patient did not improve on earlier alpha-1 blocker treatment * known hypersensitivity to alfuzosin * orthostatic hypotension in the history * concomitant application with another alpha-1 blocker * hepatic insufficiency /ast, alt 3 fold of the upper limit of the normal value/ * severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/ * intestinal obstruction /because of the castor oil content of the drug/ * tumorous disease * severe, life threatening state the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
diabetes management in low-income hispanic patients

Conditions: Type 2 Diabetes; Glycemic Control

Summary: the overall goal of this randomized clinical trial (rct) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income hispanic individuals with type 2 diabetes mellitus.

patients are randomly assigned to a usual care condition or to the cognitive behavioral intervention condition. the unit of randomization and analysis is the patient. the intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. the intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.

Eligibility criteria:
inclusion criteria: 1. diagnosed with t2dm (documented in the medical chart); 2. hba1c level \> 7.5; 3. currently treated with diet, oral hypoglycemics or insulin. if currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents; 4. hispanic origin; 5. \> 18 years old; 6. telephone in home or easy access to one; 7. able to understand and participate in the study protocol; 8. functionally capable of meeting the activity goals; 9. understands and can provide informed consent (english or spanish; for illiterate pts we will require that a representative of the pt also understands and signs the consent form on behalf of the pt); 10. physician approval to participate in the study. exclusion criteria: 1. history of diabetic ketoacidosis 2. gestational diabetes 3. unable or unwilling to provide informed consent; 4. plans to move out of the area within the 12-month study period; 5. required intermittent glucocorticoid therapy within the past 3 months; 6. experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos 7. has a medical condition that precludes adherence to study dietary recommendations (e.g., crohn's disease, ulcerative colitis, end-stage renal disease); 8. has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an atypical neuroleptic medication). we will not exclude individuals with a diagnosis of depression or pts taking anti-depressants.

Keywords: cognitive behavioral intervention low literate/illiterate hispanic patients
diagnosis and percutaneous treatment of biliary tract diseases

Conditions: Gallstone; Biliary Stricture; Biliary Diseases

Summary: this study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts. the main question it aims to answer is: - can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and/or perform endobiliary biopsies in less time than the traditional technique? participants will undergo a colangioscopic-assisted treatment using the spyglass mini-endoscopic system at the addomino-pelvic diagnostic and interventional radiology uoc of the bologna university hospital.

this is a pilot, spontaneous, non-pharmacological, prospective and single-center interventional study aimed at participants with bile duct diseases not eligible for endoscopic treatment, who, once enrolled, will undergo percutaneous colangioscopic-assisted treatment at the addominal-pelvic diagnostic and interventional radiology uoc of the university hospital of bologna. after a 24-month enrollment phase, a 36-month follow-up phase will be undertaken to assess the functional and therapeutic outcomes of this approach. the enrollment and the collection of informed consent will be carried out by the radiologists involved in the study who will also take care of the collection of clinical data and the review of all pseudoanymous radiological images pre/post treatment in order to evaluate the outcome of percutaneous treatment, the number of treatments, the duration of drainage stay, the relapse-free interval and the length of hospitalization. participants in the study will undergo treatments commonly used in daily clinical practice, including biliary clearance and/or endobiliary biopsy.

Eligibility criteria:
inclusion criteria: * radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and/or previous failed endoscopic treatment * good liver function (hemoglobin, hematocrit, got, gpt, ggt within normal ranges) * age over 18 * obtaining informed consent exclusion criteria: * presence of severe untreatable coagulopathies
promoting positive mental health for sustainable eating behaviors

Conditions: Obesity

Summary: the main aim of the present study is to assess the effects and the effectiveness of a psychological intervention based on the principles of well-being therapy (wbt) in promoting weight-loss, sustainable and healthy eating behaviors and an optimal psychological functioning in patients with obesity.

the primary objective of this pilot study is to assess the effects and the effectiveness, both post-treatment and at 1- and 3-month follow-ups, of a group intervention inspired by the principles of well-being therapy (wbt), combined with a nutritional education, compared to treatment as usual (tau), namely a basic nutritional intervention (bni) in a group setting, in terms of weight loss. the secondary objective is to evaluate the effects and effectiveness of this intervention, both post-treatment and at 1- and 3-month follow-ups, compared to bni, in promoting healthy and sustainable eating behaviors and an optimal psychological functioning. this includes the promotion of balanced psychological well-being levels and functional eating styles, and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use. after being informed about the study and its potential risks, all patients giving written informed consent will be randomly assigned to either the experimental group or the control group. both groups will participate in five weekly online group sessions of two hours each.

Eligibility criteria:
inclusion criteria patients are included in the study if they: 1. are affiliated with the clinical nutrition and metabolism unit of policlinico s. orsola-malpighi; 2. have a bmi ≥ 30; 3. are aged ≥ 18 years; 4. voluntarily agree to participate in the study; 5. have access to a computer and can use it independently. exclusion criteria patients are excluded from the study if they: 1. do not sign the informed consent to participate in the study; 2. have limited knowledge of the italian language; 3. have cognitive deficits; 4. meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors; 5. participate in another weight loss study or program; 6. take weight loss medications; 7. engage in individual or group psychotherapeutic interventions; 8. have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months); 9. (only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months).
cross-sectional iloperidone ivgtt

Conditions: Schizophrenia; Serious Mental Illness; Metabolic Syndrome; Insulin Resistance; Glucose Metabolism

Summary: this study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (fsivgtt), bergman's minimal model analysis, lipoprotein analysis, and dexa scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.

this one-month research study examines how fanapt® (iloperidone), zyprexa® (olanzapine), or risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis nos, delusional disorder or paranoid disorder. this study requires 3 research visits and includes a physical exam, medical history, vitals, an ekg, cognitive testing, psychological rating scales, a dexa scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test (ivgtt) and a fasting blood draw.

Eligibility criteria:
inclusion criteria: 1. male/female ages 18-65 years 2. capacity to provide informed consent 3. bmi between 20 and 30 kg/m² 4. diagnosis of a serious mental illness, including schizophrenia, any subtype; schizoaffective disorder, any subtype; major depressive disorder, bipolar disorder, psychosis nos, delusional disorder and paranoid disorder 5. treatment with iloperidone, risperidone, or olanzapine for at least 6 months 6. stable dose of antipsychotic agent for at least one month 7. well established compliance with out-patient medications and clinically stable 8. female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study. exclusion criteria: 1. inability to provide informed consent 2. current substance abuse 3. psychiatrically unstable and/or hospitalized in the past month 4. history of significant and untreated medical illness including severe cardiovascular, hepatic, renal, or untreated thyroid disease; hepatitis; or hiv 5. current insulin treatment for diabetes 6. currently taking the following medications: birth control pills containing norgestrol, steroids, thiazide diuretics, or treatment with agents that induce weight loss 7. intentions of donating blood during or within 30 days of completion of the study. 8. use of valproate or carbamazepine within four weeks of the study 9. history of immunosuppression 10. current or recent radiation or chemotherapy treatment for cancer 11. pregnancy or breastfeeding

Keywords: metabolic side effects atypical antipsychotics fsivgtt
language processing and tms

Conditions: Stroke; Aphasia; Language

Summary: this study will examine the effect of tms on people with stroke and aphasia as well as healthy individuals.

to examine the brain's structure and specific language function and interactive relationships, investigators will implement repetitive or rapid tms protocols in an active (or sham)-controlled, within-subject, randomized studies. aims will evaluate the effects of short-term changes on each of the semantic or phonological language process of interest in isolation and changes in the interaction between language sub-processes and their interaction with other cognitive domains that directly or indirectly affect language functions. the brain targets for tms application will be informed by existing evidence on (correlational but not causal) associations between language regions and specific language processes from numerous prior neuroimaging (e.g., functional magnetic resonance imaging or fmri) and neuropsychological studies. healthy individuals and/or stroke survivors with aphasia will be recruited to address these aims.

Eligibility criteria:
inclusion criteria: * diagnosed with left hemisphere stroke * consent date \>= 1 month after stroke onset * right-handed * fluent in english * 18 years of age or older exclusion criteria: * severe cognitive, auditory or visual impairments that would preclude cognitive and language testing * non-decisional per decisionality questionnaire or other clinical assessment * presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease) * a chronic medical condition that is not treated or is unstable * presence of 1. cardiac stimulators or pacemakers or intracardiac lines 2. neurostimulators 3. medication infusion device 4. any other implants near the scalp (e.g., cochlear implants) or in the eye 5. metal in the body * pregnancy * history of skull fractures, or skin diseases * history of ongoing or unmanaged seizures or a family history of epilepsy * presence of factors that potentially decrease seizure thresholds * on pro-convulsant medications * untreated sleep deprivation or insomnia * ongoing alcoholism or illegal drug abuse (e.g., cocaine or mdma users) * history of dyslexia or other developmental learning disabilities

Keywords: tms transcranial magnetic stimulation aphasia semantic processing phonological processing
efficacy and safety of fixed combination adapalene 0.1% / benzoyl peroxide 2.5% gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to demonstrate the non-inferior efficacy of adapalene 0.1% / benzoyl peroxide 2.5% gel when compared to clindamycin 1% / benzoyl peroxide 5% gel in subjects with acne vulgaris after a 12-week treatment period.


Eligibility criteria:
male or female subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria. main inclusion criteria: 1. male or female subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, 2. subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, 3. subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose. main exclusion criteria: 1. subjects with acne cystic lesions, 2. subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
prospective study with flot in patients with locally advanced, limited metastatic or extensive metastatic adenocarcinoma of the stomach or esophagogastric junction

Conditions: Gastric Cancer; Adenocarcinoma of the Esophagogastric Junction

Summary: patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the flot scheme (up to 12 cycles if the response is favourable). prior to enrollment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the metastatic status. patients will be classified as having either (a) locally advanced, (b) limited metastatic, or (c) extensive metastatic disease. in arms a and b surgical intervention is planned if operability is reached. the hypothesis is that by classifying patients more individually by the state of their disease, patients in arm b will have a significantly prolonged overall survival compared to patients in arm c.

250 patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the flot scheme (up to 12 cycles if the response is favourable). prior to enrolment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the m-category in the tnm classification. a prospective stratification will classify the patients as having either (a) locally advanced, (b) limited metastatic, or (c) extensive metastatic disease. in addition, the pharmacogenetic risk profile of the patients will be evaluated by a combined analysis of two genetic polymorphisms of the metabolism of the applied substances (xpd312, gstt1). for the assessment of the disease, reference regions are examined by ct or mri scans and if applicable endoscopy prior to the start of the study, every 2 months during and after the end of therapy until progression of the disease occurs. evaluation of quality of life (by standard forms like eortc-q30 and others) is continued after progression. clinical examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks for evaluation of toxicity and application of chemotherapy. after informed consent is given, peripheral blood of the patient will be analysed for the pharmacogenetic risk profile. representative tumor material will be analysed by immunohistochemistry and quantitative pcr for the expression of several molecular factors.

Eligibility criteria:
inclusion criteria: * metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction * no prior chemotherapy in metastatic state * adequate blood and biochemistry parameters exclusion criteria: * hypersensitivity for 5-fu, leucovorin, oxaliplatin or docetaxel * khk, cardiomyopathy or cardiac insufficiency * malignancy \<5 years ago * brain metastases * severe internal disease or inadequate blood and biochemistry parameters * pregnancy and lactation